At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 557 enrolled
Drug / intervention
25 mg Ontamalimab +1 moredrug
Likely dose
25 mg Ontamalimabfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
In Brief
A Phase 3 clinical trial evaluating 25 mg Ontamalimab and 75 mg Ontamalimab for Crohn's Disease and Ulcerative Colitis. Completed, enrolled 557 participants across 419 sites in 37 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Ulcerative Colitis
CountriesArgentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Colombia, Croatia, Czechia, Estonia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartFeb 2018
Primary CompletionDec 2023
TodayJul 2026
First PostedSep 14, 2017
Enrollment StartFeb 27, 2018
Primary CompletionDec 13, 2023
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 8.8 years ago
Interventions
25 mg Ontamalimabdrug
Ontamalimab SC solution for injection
75 mg Ontamalimabdrug
Ontamalimab SC solution for injection